Effects of HIIT VR Exergame on Attention and Executive Function in Young People With ADHD: A Randomized Clinical Trial With 'Move Sapiens®'

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to learn if the Move Sapiens exergame in Virtual Reality (VR), incorporated with a short model of High-Intensity Interval Training (HIIT), works as an intervention tool for adolescents with Attention-Deficit Hyperactivity/Disorder (ADHD). It will also assess the safety and effectiveness of this intervention. The main questions it aims to answer are: Does interacting with HIIT Move Sapiens® in VR improve attention and executive function in adolescents with ADHD? Does this intervention reduce other symptoms such as sleep problems and anxiety? Researchers will compare the HIIT VR exergame to a control condition. Participants will: Engage with Move Sapiens® in VR (intervention group) or participate in a control condition with an adapted version of the exergame without physical exercise (control group) (five times a week for 4 weeks). Visit the clinic for assessments and tests. The analysis will involve comparing group means using a mixed model and calculating effect sizes with Cohen's d to determine the clinical relevance of the results

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• participants with diagnosis of ADHD according to DSM-5;

• age between 12 and 17 years;

• no prior use of ADHD medication or have not been using ADHD medication for at least one month.

Locations
Other Locations
Brazil
UniEDUK-UniMax
NOT_YET_RECRUITING
Indaiatuba
Hospital de Clínicas de Porto Alegre
RECRUITING
Porto Alegre
Contact Information
Primary
Luis Augusto Rohde, PhD
larohde@hcpa.edu.br
+55 51 33598094
Backup
Pietro Merola, PhD
pietrokmerola@gmail.com
+55 51 33598094
Time Frame
Start Date: 2024-09-13
Estimated Completion Date: 2026-11
Participants
Target number of participants: 98
Treatments
Experimental: HIIT VR
The virtual reality (VR) exergame 'Move Sapiens®' will be implemented through the VR headset Oculus Quest 2 (Meta®, Menlo Park, USA). The game's objective is to take as much life from the drone as possible while avoiding being hit to preserve their own life, the drone not only moves erratically but also can attack, having a defined amount of life, just like the player. Participants will use a virtual exoskeleton to interact with the environment, and their main task is to aim and punch a drone that moves unpredictably. The exergame incorporates a short HIIT model, consisting of 12 cycles that include 16 seconds of maximum effort followed by 20 seconds of rest. This structured format is intrinsic to the game's design, aiming for a balance between effort and recovery. Essential factors for the simulation design include an engaging sensory experience of enhanced physical skills and the application of powerful punches in the game design.
Sham_comparator: Sedentary VR
Participants will play an adapted version of the 'Move Sapiens®' exergame in VR, which maintains the immersive environment of the original game but excludes any physical exercise component. In this version, interaction will be carried out exclusively through joystick manipulation, without requiring physical activity from the participants.
Sponsors
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo, Centro de Inovação em Saúde Mental (CISM), Grupo UniEDUK, University of Sao Paulo
Leads: Hospital de Clinicas de Porto Alegre

This content was sourced from clinicaltrials.gov